The digitalisation of the healthcare system is an important step towards more effective and efficient healthcare. Advances in medical technology such as Wearables, robot-assisted surgery and Artificial Intelligence (AI) are also being used more and more frequently in the healthcare sector. The EU and the German Federal Ministry of Health (Bundesministerium für Gesundheit; “BMG”) have set themselves the goal of making health data accessible for research purposes and improving healthcare through digital solutions.

The German Digital Act (Digital-Gesetz, “DigiG”) was introduced in March 2024 to simplify every-day treatment for doctors and patients with digital solutions. The most important contents include the Electronic Patient Records (ePA), which will be set up for all people with statutory health insurance at the beginning of 2025. The e-prescription has already become a binding standard in the provision of medicines in Germany and is currently being further developed.

Furthermore, the German Health Data Use Act (Gesundheitsdatennutzungsgesetz; “GDNG”) came into force in March 2024 as well. The main, but not final, contents are the establishment of a central data access and coordination centre for the use of health data in order to reduce bureaucratic hurdles and facilitate access to research data. The lead data protection authority for transnational research projects will be extended to all health data. In future, an opt-out procedure will apply to the release of data from the ePA. This will make it easier to utilise treatment data for research purposes. Only data that has been reliably and automatically pseudonymised will be transmitted.

‘Modern medicine needs digital help’, said Federal Health Minister Karl Lauterbach at the presentation of the new digitalisation strategy in March 2023. However, these modern developments are subject to strict regulatory requirements such as the European Medical Device Regulation (MDR) and the national Medical Device Law Implementation Act (Medizinprodukterecht-Durchführungsgesetz; MPDG) and pose a challenge for the development of the Metaverse around the digitalisation of medical technology. For example, the MDR and MPDG contain extensive requirements for the clinical evaluation of Wearables. As a rule, medical technology companies must conduct clinical studies and fulfil basic requirements for the safety and performance of the products.

For this reason, international companies are increasingly investing in the UK, Singapore, China and Vietnam, where the government is promoting the digitalisation of the healthcare system more strongly and setting the course for the future.

In Germany, even after facilitating the digitalisation of the healthcare system through national and European laws, there is still a need for action to create a legal framework that is open to digital innovations and does not impair the marketability of wearables, for example.

It remains to be seen whether legislators will respond to these developments with regulatory relief in order to improve Germany’s attractiveness as a centre of innovation for medical technology. Stay tuned!

unyer Working Group Health Care & Life Science
Dr. Christoph von Burgsdorff, LL.M.
Partner

Luisa Kramer
Associate